(134 days)
No
The summary describes a standard video ureteroscope system and image processor, with no mention of AI, ML, or any related capabilities in the intended use, device description, or performance studies.
Yes
The "Single-Use Digital Flexible Ureteroscope (F-URS)" is described in its intended use as being for "examination, diagnosis or treatment of urinary system diseases," which includes therapeutic applications.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Single-Use Digital Flexible Ureteroscope" is used for "imaging in examination, diagnosis or treatment of urinary system diseases."
No
The device description clearly outlines both a physical ureteroscope (hardware) and an electronic endoscope imaging processor (hardware), which together form a video ureteroscope system. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a Single-Use Digital Flexible Ureteroscope and an Electronic Endoscope Imaging Processor. Their intended use is for imaging within the urinary system for examination, diagnosis, or treatment. They directly visualize the internal anatomy.
- Lack of Specimen Analysis: The device does not analyze samples taken from the body. It provides real-time visual information of the body's internal structures.
Therefore, while it's a medical device used for diagnosis and treatment, it falls under the category of an endoscopic imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases.
Endoscope Imaging Processor (ZSR-EOS10) :
Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.
Product codes
FGB
Device Description
-
Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube. -
Electronic Endoscope Imaging Processor (ZSR-EOS10)
Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components.
The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary system diseases, urinary tract and kidney
Indicated Patient Age Range
Adults
Intended User / Care Setting
The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures.
The device is for use in a hospital or qualified medical institution.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical study is included in this submission.
The device described in this summary was tested and demonstrated to be in conformance with the following standards:
Performance testing:
- ISO16926-6:2014
- ISO 8600-5:2020
- IEC 62471:2006
- ISO 8600-1:2015
- ISO 8600-4:2014
- ISO 12233:2017
- ISO 15739:2017
- ISO/CIE 11664-4
- Wanq, et al., "Development of the local maqnification method for quantitative evaluation of endoscope geometric distortion." Journal of Biomedical Optics 21, no. 5 (2016): 056003Wang et al., "Endoscope field of view measurement." Biomedical Optics Express 8, no. 3(2017):1441-1454.
- Wei-Chung Cheng, "Color Performance Review (CPR): A Color Performance Analyzer for Endoscopy Devices" in Journal of Imaging Science and Technology, 2023, pp1 -9, https://doi.org/10.2352/.lmagingSci.Technol.2023.67.5.050406
Biocompatibility testing:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic
- Pyrogenicity
Sterility and Shelf -life:
- ISO 11135:2014
- ISO 11737-1:2018
- ISO11737-2:2019
- ISO 10993-7: 2008
- ASTM F1980-2016
- ASTM F88/F88M-15
- ASTM D4169-23e1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" also in blue.
February 11, 2025
Dongguan ZSR Biomedical technology Company Limited % Kang Kyra Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai, 200072 CHINA
Re: K243155
Trade/Device Name: Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Received: January 3, 2025
Dear Kang Kyra:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page
2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243155
Device Name
Single-Use Digital Flexible Ureteroscope(F-URS)(ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Electronic Endoscope Imaging Processor(ZSR-EOS10)
Indications for Use (Describe)
Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases.
Endoscope Imaging Processor (ZSR-EOS10) :
Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
l. Submitter
Dongguan ZSR Biomedical technology Company Limited Unit 448, Qingfeng Road, Taihu Village, Sanzhong Village Committee, Qingxi Town, 523651 Dongguan City, Guangdong Province,PEOPLE'S REPUBLIC OF CHINA Contact person: Mrs. Sharon Wen Position: Management Representative Tel.:+86-13728363586 E-mail: Sharon@zsrbiomedical.com
Preparation date: January 30, 2025
Submission Correspondent Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com
II. Proposed Device
| Device Trade Name: | Single-Use Digital Flexible Ureteroscope (F-URS: ZSR-
URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
Electronic Endoscope Imaging Processor (ZSR-EOS10) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product code: | FGB |
| Review Panel: | Gastroenterology/Urology |
III. Predicate Devices
| 510(k) Number: | K230200 |
|---|---|
| Trade name: | Single-Use Flexible Ureteroscope |
| Common name: | Endoscope and Accessories |
| Classification: | Class II |
| Product Code: | FGB |
| Manufacturer | Hunan Vathin Medical Instrument Co., Ltd |
IV. Reference Devices
5
K243155 Page 2 of 6
| 510(k) Number: | K221158 |
|---|---|
| Trade name: | Single-Use Video Flexible Ureterorenoscope System |
| Common name: | Endoscope and Accessories |
| Classification: | Class II |
| Product Code: | FGB |
| Manufacturer | Guangzhou Red Pine Medical Instrument Co., Ltd. |
V. Device description
-
Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube.
> Electronic Endoscope Imaging Processor (ZSR-EOS10)
Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components.
The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.
VI. Indication for use
Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04): This product is used in medical institutions, in conjunction with our Electronic Endoscope Imaging Processor, for imaging in examination, diagnosis or treatment of urinary system diseases.
Electronic Endoscope Imaging Processor (ZSR-EOS10): This product is used in medical institutions, in conjunction with our Single-Use Digital Flexible Ureteroscope, for imaging in examination, diagnosis or treatment of urinary system diseases.
VII.Comparison of technological characteristics with the predicate devices
6
| Character
istics | Proposed device | Predicate device
(K230200) | Discussion | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------|
| Trade
name | Single-Use Digital Flexible
Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-
URS-03, ZSR-URS-04)
Electronic Endoscope Imaging
Processor (ZSR-EOS10) | Single-Use Flexible
Ureteroscope | / | |
| Classification
Name | Ureteroscope And
Accessories, Flexible/Rigid | Ureteroscope And
Accessories, Flexible/Rigid | Same | |
| Product
Code | FGB | FGB | Same | |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | |
| Indications
for
use | Single-Use Digital Flexible
Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-
URS-03, ZSR-URS-04): This
product is used in medical
institutions, in conjunction with
our Electronic Endoscope
Imaging Processor, for
imaging in examination,
diagnosis or treatment of
urinary system diseases.
Electronic Endoscope Imaging
Processor (ZSR-EOS10): This
product is used in medical
institutions, in conjunction with
our Single-Use Digital Flexible
Ureteroscope, for imaging in | The Single-use Flexible
Ureteroscope is
designed for use with Vathin
Display
Units, endotherapy
accessories and other
ancillary devices for the
endoscopy and
endoscopic surgery within
urinary tract
and kidney in adults. | Same | |
| | | treatment of urinary system diseases. | | |
| Application | field | The device is for use in a hospital or qualified medical institution. | The device is for use in a hospital or qualified medical institution. | Same |
| Intended | user | The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures. | The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures. | Same |
| Patient | | Adults | Adults | Same |
| population | | | | |
| Scope | type | Flexible | Flexible | Same |
| Field of | view (degree) | $120°±10°$ | $110°$ | Same |
| Direction | of view (degree) | $0°$ | $0°$ | Same |
| Bending | angle (degree) | Up 275 °/down 275 ° (tolerance -10%, upper limit not included) | Up: 285°
Down: 285° | Same |
| Maximum | insertion portion width(mm) | ZSR-URS-01, ZSR-URS-02: 2.85
ZSR-URS-03, ZSR-URS-04: 2.50 | US-S170, US-E170: 3.15
US-S180, US-E180: 3.25 | Similar 1 |
| Minimum | insertion channel width(mm) | ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04: 1.2 | US-S170, US-E170: 1.2
US-S180, US-E180: 1.4 | Same |
| Working
length
(mm) | 670mm, tolerance ± 10% | 700 | Same | |
| | Digital
video
technology | CMOS | CMOS | Same |
| Illuminatio
n
source | LED | LED | Same | |
| Single-use | Yes | Yes | Same | |
| Biocompat
ibili
ty | No Cytotoxicity
No Irritation to Skin
No significant evidence of
sensitization | No Cytotoxicity
No Irritation to Skin
No significant evidence of
sensitization | Same | |
| Sterilizatio
n | EO | EO | Same | |
7
8
Analysis 1 -
Only differences in specifications and dimensions. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.
VIII.Non-Clinical Testing
The device described in this summary was tested and demonstrated to be in conformance with the following standards:
Performance testing:
- ISO16926-6:2014 >
- ISO 8600-5:2020 V
-
IEC 62471:2006
- V ISO 8600-1:2015
-
ISO 8600-4:2014
- ISO 12233:2017 V
- ISO 15739:2017 >
9
- ISO/CIE 11664-4 >
-
Wanq, et al., "Development of the local maqnification method for quantitative evaluation of endoscope geometric distortion." Journal of Biomedical Optics 21, no. 5 (2016): 056003Wang et al., "Endoscope field of view measurement." Biomedical Optics Express 8, no. 3(2017):1441-1454.
-
Wei-Chung Cheng, "Color Performance Review (CPR): A Color Performance Analyzer for Endoscopy Devices" in Journal of Imaging Science and Technology, 2023, pp1 -9, https://doi.org/10.2352/.lmagingSci.Technol.2023.67.5.050406
Biocompatibility testing
Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA quidance "Use of International Standard ISO 10993-1" The following testing was conducted:
-
Cytotoxicity
-
Sensitization
-
Irritation
-
Acute Systemic
-
Pyrogenicity
Sterility and Shelf -life
- ISO 11135:2014 V
-
ISO 11737-1:2018
- ISO11737-2:2019 >
-
ISO 10993-7: 2008
-
ASTM F1980-2016
-
ASTM F88/F88M-15
- ASTM D4169-23e1 >
IX. Clinical Testing
No clinical study is included in this submission.
X. Conclusion
The proposed device has the same indications for use and has similar design features and technological characteristics as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.